Radiopharmaceuticals, unlicensed

It should not be necessary to perform other chemical tests on licensed radiopharmaceuticals. Unlicensed radiopharmaceuticals should be checked for chemical purity to ensure the quality of the product. This would include the quantification of the normal constituents of a labeling kit, i.e., the ligand and re-ductant. Synthesis precursors or catalysts used in the preparation should be tested for. Commonly, this can be carried out using HPLC. Gas chromatography methods are used to test PET tracers for residual solvents used in the synthesis of these agents. 

Up to now unlicensed radiopharmaceuticals (e.g., C-raclopride, F-fluoride for bone scintigraphy, etc.) the manufacturer, i.e., the local radiopharmacy, has to perform a full analysis according to the monograph of the Ph. Eur. 

Test Tc " radiopharmaceuticals from licensed kits Ready-to-use licensed products PET radiopharmaceuticals Research and unlicensed products... 

Purchase of a ready to use or ready to administer radiopharmaceutical (licensed or unlicensed) ... 

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